Orthofix Prefix II Diaphyseal Kit Recalled for Drill Bit Design Defect
Orthofix is recalling Prefix II Diaphyseal Complete Kits because drill bits have a design defect that may reduce cutting performance.
What this means for you
Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.
Our severity reasoning: The FDA classified this as a Class II recall. The hazard involves reduced cutting performance due to a design defect, which is a functional issue rather than a direct risk of serious injury or death, fitting the Moderate criteria for minor defects or low-risk issues.
Plain-English summary
Orthofix Srl is recalling the Prefix II Diaphyseal Complete Kit (Catalogue Number: 99-92502) due to a defect in the drill bits included in the kit. The FDA classified this recall as Class II.
Complaint investigations revealed that the drill bits have a geometrical detail that does not match the intended design. This discrepancy could result in lower cutting performance during use.
The affected product is a sterile, prescription-only medical device. The specific lot number is B1209789. The source text notes that this specific lot was not marketed in the US, though the product was distributed in various US states and internationally. Healthcare providers should stop using the affected kits and contact Orthofix for further instructions.
The recalled product
- Product
- ORTHOFIX Catalogue Number: ref: 99-92502, PREFIX II DIAPHYSEAL COMPLETE KIT STERILE NO SCREWS, RX ONLY, UDI: (01) 18033509855955
- Manufacturer
- Orthofix Srl
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (1)
- Lot # B1209789 *Not marketed in US
Distribution
Part of a larger recall action
This product is one of 31 recalled by Orthofix Srl under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
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